Reusable Versus Disposable Duodenoscopes for ERCP

AdventHealth

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Device: endoscopic retrograde cholangiopancreatography

Study type: Interventional

Funder types: Other

Identifiers

NCT04143698

1388902

Details and patient eligibility

About

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Full description

Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes.

The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. Patients with native papilla
3. Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography

Exclusion criteria

1. Age <18 years old
2. Unable to obtain informed consent
3. Pregnancy
4. Altered upper gastrointestinal surgical anatomy
5. Patients with percutaneous transhepatic biliary drainage catheters
6. Prior history of ERCP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

98 participants in 2 patient groups

Disposable (single-use) duodenoscope

Active Comparator group

Description:

This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).

Treatment:

Device: endoscopic retrograde cholangiopancreatography

Reusable duodenoscope

Active Comparator group

Description:

This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).

Treatment:

Device: endoscopic retrograde cholangiopancreatography